Knee Products: 155308 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 65 MM 155326 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM 155330 Knees AGC Knee System PS Molded Tibial Component, 14 MM X 70 MM 155344 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 75 MM 155346 Knees AGC Knee System PS Molded Tibial Component, 12 MM X 75 MM 155326 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM 155328 Knees AGC Knee System PS Molded Tibial Component, 12 MM X 70 MM 155388 Knees AGC Knee System PS Molded Tibial component, 18 MM X 85 MM Product Usage: Knee prosthesis

Reason: Potential presence of elevated endotoxin levels that exceed the specification limit

Code information: Lot Numbers: UDI Number 570460 AGC Knee System PS Molded Tibial Component, 10 MM X 65 MM (01)00880304000865(17)220111(10)570460 515880 AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM (01)00880304000193(17)220106(10)515880 602810 AGC Knee System PS Molded Tibial Component, 14 MM X 70 MM (01)00880304246034(17)220105(10)602810 494090 AGC Knee System PS Molded Tibial Component, 10 MM X 75 MM (01)00880304003781(17)220106(10)494090 505320 AGC Knee System PS Molded Tibial Component, 12 MM X 75 MM (01)00880304246096(17)220106(10)505320 578470 AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM (01)00880304000193(17)220114(10)578470 447820 AGC Knee System PS Molded Tibial Component, 12 MM X 70 MM (01)00880304000179(17)220118(10)447820 494030 AGC Knee System PS Molded Tibial component, 18 MM X 85 MM (01)00880304246256(17)220118(10)494030

Distribution pattern: Worldwide distribution - US Nationwide distribution and the countries of Canada, AHMADABAD, GUJARAT, BANGKOK, BELROSE NSW, BUENOS AIRES, CHILE, COSTA RICA, HIRATSUKA CITY, HUECHURABA SANTIAGO, INDIA, JAPAN, MEXICO DF, NETHERLANDS, PICHINCHA, EC, SAN JOSE, SINGAPORE, TAIWAN, THAILAND, YONGSAN-GU SEOUL.